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Endovascular challenges for the next decade

>>0 >>1 >> 2 >> 3 >> 4 >> The ART of endovascular therapy

>>0 >>1 >> 2 >> 3 >> 4 >> The way to your heart! Radial approach Femoral approach Brachial approach

>>0 >>1 >> 2 >> 3 >> 4 >> Oct 30th, The diagnostic coronary angiogram Dr. Mason Sones of the Cleveland Clinic conducts an imaging procedure of a child’s aortic valve, “accidentally engaging the right coronary artery and injecting dye”. When the patient’s heart did not display the expected fibrillation, Sones realized he had discovered the key to selective imaging of the heart – the diagnostic coronary angiogram.

>>0 >>1 >> 2 >> 3 >> 4 >> Oct 30th, The diagnostic coronary angiogram Dr. Mason Sones of the Cleveland Clinic conducts an imaging procedure of a child’s aortic valve, “accidentally engaging the right coronary artery and injecting dye”. When the patient’s heart did not display the expected fibrillation, Sones realized he had discovered the key to selective imaging of the heart – the diagnostic coronary angiogram.

>>0 >>1 >> 2 >> 3 >> 4 >> PCI 1977 : First cath lab balloon angioplasty performed on an awake patient by Gruentzig in Zurich, and the first case entered into a worldwide registry 1987 : First used by Dr. Ulrich Sigwart in, coronary stents now play a dominant role in interventional cardiology procedures worldwide : RAVEL precedes the current Drug-Eluting Stent Era, marking a major advance in the battle to reduce restenosis to single digits.

>>0 >>1 >> 2 >> 3 >> 4 >> PCI 1977 : First cath lab balloon angioplasty performed on an awake patient by Gruentzig in Zurich, and the first case entered into a worldwide registry 1987 : First used by Dr. Ulrich Sigwart in, coronary stents now play a dominant role in interventional cardiology procedures worldwide : RAVEL precedes the current Drug-Eluting Stent Era, marking a major advance in the battle to reduce restenosis to single digits.

>>0 >>1 >> 2 >> 3 >> 4 >> Treatment of AMI Aspirin –400BC: Hippocrates prescribes bark and leaves of the Willow tree (Salix alba) –Salicin (1829)  Salicylic acid (1832)  Acetylsalicylic acid (1853) –Patented on March 6 th, 1889 (Bayer) A- : from acetyl group -spir- : from Spiraea flower -in : common ending for drugs at the time –Related to the treatment of AMI since 1948 but routinly used since 70’s.

>>0 >>1 >> 2 >> 3 >> 4 >> Treatment of AMI Thrombolysis

>>0 >>1 >> 2 >> 3 >> 4 >> Keeley et al. Lancet ;361: 13–20. Frequency, % DeathDeath, Excluding SHOCK Data Non-fatal Myocardial Infarction Recurrent Ischemia Total Stroke Haemorrhagic Stroke Major Bleed Death, Non-fatal Reinfarction, or Stroke Long-Term Outcomes Short-Term Outcomes P = P = P < P = P = P < P = P < P = PTCA Thrombolytic therapy DeathDeath, Excluding SHOCK Data Non-fatal Myocardial Infarction Recurrent Ischemia Total Stroke Haemorrhagic Stroke Major Bleed Death, Non-fatal Reinfarction, or Stroke Thrombolysis vs. PCI in STEMI

>>0 >>1 >> 2 >> 3 >> 4 >> PCI in the treatment of AMI Occluded RCA Aspiration of thrombus Direct stenting Nice result

>>0 >>1 >> 2 >> 3 >> 4 >> Current affairs >45 Clinical trials High-technological diagnostic tools High-technological therapeutical tools IABP Virtual Histology Palpography Rotablator ELCA Laser

>>0 >>1 >> 2 >> 3 >> 4 >> Act from the heart…

>>0 >>1 >> 2 >> 3 >> 4 >> …work on the brain

>>0 >>1 >> 2 >> 3 >> 4 >> Treatment of carotid stenosis Goal –Prevention of stroke Means –Carotid endarterectomy (CEA) –Carotid artery stenting (CAS)

>>0 >>1 >> 2 >> 3 >> 4 >> Carotid Endarterectomy (1) Carotid Endarterectomy –>50 years –Peri-operative combined mortality and major stroke risk is 2 – 5% (6.5% in NASCET) Indicatons –Symptomatic patients % stenosis (NNT 6 to prevent 1 major stroke at 2 years) –Symptomatic patients + >60% stenosis still benefit, but less NASCET (North American Symptomatic Carotid Endarterectomy Trial) –Asymptomatic patients + >75% stenosis ACST (European asymptomatic carotid surgery trial)

>>0 >>1 >> 2 >> 3 >> 4 >> Carotid Endarterectomy (2) Contra-indications –Complete internal carotid artery obstruction (because the intraluminal thrombus then extends too far downstream, well into the intracranial portion of the artery, for endarterectomy to be successful) –Previous stroke on the ipsilateral side with heavy sequelae because there is no point in preventing what has already happened –Patient deemed unfit for the operation by the anaesthesiologist

>>0 >>1 >> 2 >> 3 >> 4 >> Carotid Endarterectomy (3) The long term benefits of carotid endarterectomy for both symptomatic and asymptomatic patients need to be weighed against the immediate risk of complications of the procedure, thus benefit is tangible only in the presence of a low perioperative complication rate. The surgical procedure should be performed by an experienced surgeon with good patient selection and as such continues to be the gold standard

>>0 >>1 >> 2 >> 3 >> 4 >> A good stent is as good as a good endarterectomy Horst Sievert, MD

>>0 >>1 >> 2 >> 3 >> 4 >> Stent trials CAVATAS SAPPHIRE EVA-3S SPACE

>>0 >>1 >> 2 >> 3 >> 4 >> CAVATAS Carotid and Vertebral Artery Transluminal Angioplasty Study The Lancet 2001; 357:

>>0 >>1 >> 2 >> 3 >> 4 >> Study design Endovascular treatment (n=251) 504 patients with carotid stenosis Carotid endarterectomy (n=253) 74% balloon angioplasty (n=158) 26% stents (n=55)

>>0 >>1 >> 2 >> 3 >> 4 >> Outcome

>>0 >>1 >> 2 >> 3 >> 4 >> 3 year outcome

>>0 >>1 >> 2 >> 3 >> 4 >> Conclusion Endovascular treatment had similar major risks and effectiveness at prevention of stroke during 3 years compared with carotid surgery, but with wide CIs. Endovascular treatment had the advantage of avoiding minor complications. PS: Distal emboli-protection devices were not routinely used

>>0 >>1 >> 2 >> 3 >> 4 >> SAPPHIRE Protected Carotid-Artery Stenting versus Endarterectomy in High-Risk Patients N Engl J Med Volume 351;15: October 7, 2004

>>0 >>1 >> 2 >> 3 >> 4 >> Study design Endovascular treatment (n=167) 334 high risk patients with carotid stenosis Symptomatic + 50% or Asymptomatic + 80% stenosis Carotid endarterectomy (n=167) 100% Distal emboli-protection devices

>>0 >>1 >> 2 >> 3 >> 4 >> Major eligibility criteria

>>0 >>1 >> 2 >> 3 >> 4 >> Cumulative Incidence of Adverse Events at 30 days and within 1 Year At 30 daysAt 1 Year ?

>>0 >>1 >> 2 >> 3 >> 4 >> Conclusions Among patients with severe carotid-artery stenosis and co-existing conditions, carotid stenting with the use of an emboli-protection device is not inferior to carotid endarterectomy. Therefore, the less invasive approach may be an acceptable alternative among patients with high- risk carotid-artery stenosis.

>>0 >>1 >> 2 >> 3 >> 4 >> EVA-3S Endarterectomy versus Stenting in Patients with Symptomatic Severe Carotid Stenosis N Engl J Med, Volume 355(16): , October 19, 2006

>>0 >>1 >> 2 >> 3 >> 4 >> Study design Endovascular treatment (n=247) 527 patients with carotid stenosis ≥60% + Σ Carotid endarterectomy (n=257) 91.1% Distal emboli-protection devices (change in protocol during study – 1/3 without recommendation)

>>0 >>1 >> 2 >> 3 >> 4 >> EVA-3S Primary 30d Carotid Stenting vs Endarterectomy 0.8%1.2%0.7 ( )0.68 Relative Risk ± 95% CI Relative Risk ± 95% CI Endpoint Death Stroke Death/Stroke Stenting better CEA better CEA (n=259) Stenting (n=261) RR (95% CI) unadjusted p-value 8.8%2.7%3.3 ( ) % 3.9%2.5 ( )0.01 Mas JL et al. N Engl J Med 2006

>>0 >>1 >> 2 >> 3 >> 4 >> EVA 3S What was different from the other trials?

>>0 >>1 >> 2 >> 3 >> 4 >> EVA-3S Initially embolic protection was optional –5/20 pts without embolic protection suffered from a stroke! Experienced Surgeons, unexperienced Interventionalists –Surgeons: >25 endarterectomies /year –Interventionalists: Only 12 carotid stenting procedures were required –Regardless of the result Some operators were even in training phase!

>>0 >>1 >> 2 >> 3 >> 4 >> EVA-3S Unexperienced centers –1.7 pts/year Aspirin + Plavix was not mandatory –Not prescribed in 15% ! 2.4 % did not receive heparin! Patients with high surgical risk were excluded –But patients with high stent risk not!

>>0 >>1 >> 2 >> 3 >> 4 >> SPACE Stent-Protected Angioplasty versus Carotid Endarterectomy Lancet 2006;368:

>>0 >>1 >> 2 >> 3 >> 4 >> Study design Carotid stenting (n=605) 1900 patients with carotid stenosis ≥70% + neurological symptoms Carotid endarterectomy (n=595) 27% Distal emboli-protection devices Stopped premature at 1200 ptn

>>0 >>1 >> 2 >> 3 >> 4 >> SPACE Trial stopped after the second interim- analysis (n=1200) –Patient recruitment too slow –Funding too low –Statistical power too low (37% chance for false negative conclusion)

>>0 >>1 >> 2 >> 3 >> 4 >> SPACE Primary Endpoint: Ipsilateral Stroke and 30 Days n.s.

>>0 >>1 >> 2 >> 3 >> 4 >> SPACE Primary Endpoint: Ipsilateral Stroke and 30 Days

>>0 >>1 >> 2 >> 3 >> 4 >> SPACE "SPACE failed to prove non-inferiority of stenting compared with endarterectomy" No significant difference regarding the primary end-point No significant differences between CAS and CEA –Regarding secondary endpoints –Subgroups

>>0 >>1 >> 2 >> 3 >> 4 >> SPACE: Important to know Many centers/investigators had problems to fulfill the entrance criteria –Which were low! Only 25 carotid stent procedures! Limited availability of embolic protection devices (only few were allowed) –Some operators had limited experience with those embolic protection devices allowed in the trial 73% of CAS performed without embolic protection

>>0 >>1 >> 2 >> 3 >> 4 >> SPACE: Important to know Not included as end-points (primary or secondary) –Myocardial infarction –Contralateral stroke –Cranial nerve palsy –Length of hospital stay –Other MAE Again, patients with high surgical risk were excluded but not patients with high stenting risk

>>0 >>1 >> 2 >> 3 >> 4 >> SPACE: Important to know Complete data monitoring in only 10% of the patients in each centre Trial stopped early Large pt numbers but still underpowered

>>0 >>1 >> 2 >> 3 >> 4 >> Don’t judge too quickly

>>0 >>1 >> 2 >> 3 >> 4 >> SPACE did not show a difference between surgery and stenting, but imagine … … an excellent clinical trial –with experienced operators –randomized –controlled/monitored –multicenter –including all relevant endpoints –well powered  would show superiority of carotid surgery compared to stenting

>>0 >>1 >> 2 >> 3 >> 4 >> Then we would have the same situation as with coronary stenting We have a number of excellent clinical trials PCI versus CABG –with experienced operators –randomized –controlled/monitored –multicenter –including all relevant endpoints –well powered  Showing superiority of CABG compared to PCI and coronary stenting

>>0 >>1 >> 2 >> 3 >> 4 >> Why is that? Nobody cares! Number of PCIs goes up, number of CABG goes down!

>>0 >>1 >> 2 >> 3 >> 4 >> Take Home Messages In high grade carotid stenoses surgery is better than medical therapy The results of stent implantation are comparable to the results of surgery Therefore stent implantation is a treatment option in high grade stenosis EVA 3S and SPACE have shown again that stenting requires training and experience Nobody wants surgery

>>0 >>1 >> 2 >> 3 >> 4 >> Why should we stay behind? We could start with a adjustedscreening program n

>>0 >>1 >> 2 >> 3 >> 4 >> Patient selection All specifically referred patients + All patients send for coronarography and/or left-right catheterization, who are planned for CABG and/or valve surgery

>>0 >>1 >> 2 >> 3 >> 4 >> Examinations Non-invasive –Duplex Carotids Invasive –Angiography using substraction and/or rotational

>>0 >>1 >> 2 >> 3 >> 4 >> Duplex criteria <1.5 <40 <120 <40% Nonstenotic plaque >90%Ca. 80%60-70%40-60% Angiographic estimates Variable>3.7>1.8<1.8 Systolic ratio (ICA/CCA) Variable>100>40<40 End diastolic velocity (cm/s) Variable>240>120 Systolic peak velocity (cm/s) Subtotal stenosis High-grade stenosis Medium-grade stenosis Low-grade stenosis

>>0 >>1 >> 2 >> 3 >> 4 >> Duplex Carotids

>>0 >>1 >> 2 >> 3 >> 4 >> Angiography (1) Aortic arch angio –6F Pigtail –45-50° LAO, no angulation –Automated injection (750 psi) 30 cc at 15 cc/s

>>0 >>1 >> 2 >> 3 >> 4 >> Angiography (2) Substraction –JR4 or SIM 1/2 catheter –Manual injection (min. 5cc dye/inj) 3x left CA, 3x right CA + 2x vertebral (0° angulation) 2x left cerebral, 2x right cerebral (15° cranial)

>>0 >>1 >> 2 >> 3 >> 4 >> Angiography (2) Rotational –SIM 1/2 catheter –RAO 120°  LAO 120°, 0° angulation –Automated injection (450 psi !!) Carotids: 2x 16cc at 4cc/s met 0.5sec delay Cerebral: 2x 16cc at 4cc/s and 1.5sec delay –Manual injection of vertebral artery

>>0 >>1 >> 2 >> 3 >> 4 >> Let’s dream of a better world

>>0 >>1 >> 2 >> 3 >> 4 >> For further slides on these topics please feel free to visit the metcardio.org website: